bis licence under foreign manufacturers certification scheme (fmcs)

24
BIS LICENCE UNDER FOREIGN MANUFACTURERS CERTIFICATION SCHEME (FMCS) Priyank Srivastava

Upload: priyank-srivastava-rph

Post on 12-Apr-2017

134 views

Category:

Healthcare


3 download

TRANSCRIPT

BIS LICENCE UNDER FOREIGN MANUFACTURERS CERTIFICATION

SCHEME (FMCS)

Priyank Srivastava

PROCEDURE FOR GRANT AND OPERATION OF BIS LICENCE UNDER FOREIGN MANUFACTURERS CERTIFICATION

SCHEME (FMCS)

•In this scheme, a licence to use the Certification Mark of the Bureau ofIndian Standards, called the Standard Mark, can be granted by BIS for anyproduct against an Indian Standard.

•The BIS licence is granted indicating location as the manufacturingaddress at which the manufacturing takes place, final product is tested asper the relevant Indian Standards and conforming product is applied withthe BIS Standard Mark.

• The liability of non-conformance of the Standard Marked product, if any,solely rests with the manufacturer. The role of the Bureau, as the third-party certification agency, is limited to supplementing information toconsumers that the product has been manufactured under a well-definedsystem of inspection and testing to establish its conformity to thecorresponding Indian Standard.

•“Manufacturer” means a business enterprise engaged in the manufacture ofany article or process, situated at a stated location or locations, that carriesout and controls such stages in the manufacture, assessment, handling orstorage of a product, that enables it to accept responsibility for continuedcompliance of the product with the relevant Indian Standard andundertakes all obligations in that connection, with regard to grant of BISlicence to foreign manufacturer, under the Scheme.

•Through its surveillance operations, BIS maintains a close vigil on thequality of products certified.

PROCEDURE FOR GRANT AND OPERATION OF BIS LICENCE UNDER FOREIGN MANUFACTURERS CERTIFICATION

SCHEME (FMCS)

The foreign manufacturer shall set up a liaison / branch office located in India with the permission of Reserve Bank of India, which shall meet all liabilities with respect to BIS Act, Rules and Regulations for purpose of the BIS licence.

The requirement to set up an office in India shall not apply if the foreign manufacturer nominates a legally appointed Agent, located in India, who declares his consent to be responsible for compliance to the provisions of the BIS Act, 1986; Rules and Regulations framed there under, and terms & conditions of the BIS licence, including agreement, undertakings, etc.

In case of any change in the address of such Liaison / Branch Office of the foreign manufacturer or of its legally appointed Indian Agent, the foreign manufacturer is required to obtain prior consent of BIS in that regard before effecting such change of address.

The foreign manufacturer shall submit an undertaking to BIS that all the liabilities with respect to ensuring compliance to the BIS Act, Rules and Regulations

APPLICATION FORM, CHECK-LIST AND

APPLICATION FEE

Those desirous of obtaining the BIS licenses shall have to apply to BIS in the Application Form along with requisite Application Fee (Schedule of Fee Structure).

Separate application is required to be submitted for each product / Indian Standard.

At the time of submission of the application, the documents given in the check list shall also be required to be attached.

THE APPLICANT SHOULD SATISFIES THE FOLLOWING CONDITIONS

a) Complete manufacturing facilities for the product are available in-housein the applicant’s factory at the address indicated in the application form (else,details of alternate arrangements made are to be provided);

b) Complete testing facilities for the product in accordance with therelevant Indian Standard are available in-house in the applicant’s factory at theaddress indicated in the application form (else, details of alternatearrangements made are provided);

c) Competent testing personnel are permanently employed, whounderstand the requirements of the relevant Indian Standards and arecompetent to carry out tests for various characteristics as per the test methodsprescribed in the relevant Indian Standards;

THE APPLICANT SHOULD SATISFIES THE FOLLOWING CONDITIONS

d) The product conforms to the relevant Indian Standard (assessed aftertesting of a sample of the product in the applicant’s in-house laboratory and/ or in an accredited independent laboratory for all the requirements as perrelevant Indian Standard) and a copy of the test report(s), so generated,is(are) attached with application;

e) Agrees to comply with requirements laid down in a document, called“Scheme of Testing & Inspection (STI)”. This STI (different for differentIndian Standards) includes frequency of inspection and testing for variouscharacteristics of the Indian Standard, which, as a part of process control,are required to be carried out by the licensee after the grant of BIS licenceand appropriate records maintained. Copies of STIs are available with BISand can be obtained at any time on request and / or at the time ofsubmission or recording of application or during the visits by BIS inspectingofficers, and

f) Undertakes to pay the requisite fee to BIS.

PRELIMINARY INSPECTION

1 The application submitted by the applicant to BIS will be scrutinized,and if found to be complete in all respects, it will be recorded. If, onscrutiny, the application is found to be incomplete, the applicant will beinformed accordingly.

2 After recording of the application, preliminary inspection shall becarried out at the applicant’s manufacturing and testing address(es) by BISinspecting officer(s) or its agent.

3 The cost of preliminary inspection by BIS shall be borne by theapplicant, which shall include the cost to BIS of the man-days spent by BISofficer(s), the expenditure towards travel, stay and per diem, as applicablefor the BIS officer(s) as per the relevant norms of the Bureau.

4 In case the preliminary inspection is carried out by an agent of BIS, thefees shall be arranged directly between the applicant and the agent. Theapplicant shall make early arrangements for inspection, includingfacilitating issuance of visa to the inspecting officer(s).

5 During the preliminary inspection, the competence of the applicantwill be checked in respect of:

a) availability of requisite in-house manufacturing and testingfacilities as per the relevant Indian Standard(s);

b) competence of permanently employed testing personnel; and

c) conformity of the product sample(s) to the relevant requirementsof the Indian Standard, when checked in the applicant’s factory duringthe preliminary inspection.

6 Sample(s) shall be drawn for independent testing, which the applicanthas to deposit with the laboratory indicated by BIS inspecting officer(s) orits agent. The cost of testing of the sample(s) shall be borne by theapplicant. The discretion to choose the laboratory shall rest solely with BIS.

GRANT OF LICENCE

1 The BIS licence is granted in accordance with the Regulation 4 of theBIS (Certification) Regulations, 1988. The BIS licence is granted to anapplicant, if:

a) the results of preliminary inspection carried out by BISofficer(s) (see 2.5) are satisfactory,

b) the sample(s) drawn during the preliminary inspection forindependent testing are found conforming to the relevant IndianStandard(s) for all the requirements, and

c) the applicant agrees to comply with requirements given in therelevant STI,

d) the applicant agrees to pay the annual minimum marking feeand the licence fee to BIS, and

e) the applicant agrees to enter into an Agreement with BIS fordue compliance of the terms and conditions of the licence as given inRegulation 5 of the BIS (Certification) Regulations, 1988.

2 Immediately after grant of the BIS licence, the licensee shall payannual minimum marking fee and annual licence fee toBIS. Subsequently, the licensee is required to pay the marking fee,quarterly, on the basis of the production covered under the StandardMark during the quarter, as per the accepted marking fee rates.

3 The BIS licence, so granted, shall be valid for one year.

AGREEMENT WITH BIS

The applicant shall enter into an Agreement with BIS for duecompliance of the terms and conditions of the licence, as given in theBIS (Certification) Regulations, 1988. The Agreement between BISand the licensee / manufacturer shall include provision for fees,nomination, rights and responsibilities of licensee, determination /termination, indemnity, performance bank guarantee, non-renewal,cancellation of licence, etc.

OPERATION OF LICENCE AND

SURVEILLANCE INSPECTIONS

1 Surveillance inspections, as per the provisions given in the BIS(Certification) Regulations, 1988, shall be carried out by BIS or itsagent to assess the performance of operation of the licence by theforeign BIS licensee. The cost of inspection by BIS shall be borne bythe licensee, which shall include the cost to BIS of the man-daysspent by BIS officer(s), the expenditure towards travel, stay and perdiem, as applicable for BIS officer(s) deputed for the surveillanceinspection as per the BIS (Terms and Conditions of Service ofEmployees) Regulations, 2007.

2 If inspection is carried out by an Agent of BIS, the fees shall bearranged directly between the licensee and the Agent.

3 Sample(s) shall also be drawn during the surveillance inspectionfor independent testing by BIS at its own laboratory and/orlaboratory(ies) recognized by it for ascertaining conformance of theproduct to the relevant Indian Standard. The cost of testing of thesample(s) shall be borne by BIS. However, in case of products forwhich the cost of testing is high, the testing charges shall be borne bythe licensee. The decision in this regard shall rest solely withBIS. Further, the discretion to choose the independent laboratoryshall also rest solely with BIS.

4 Sample(s) shall also be drawn by BIS from market duringoperation of the licence. The cost of market samples, thus drawn,shall be borne by BIS. The cost of testing of the sample(s) shall beborne by BIS. However, in case of products for which the cost oftesting is high, the testing charges shall be borne by licensee. Thedecision in this regard shall rest solely with BIS.

CONSUMER COMPLAINTS

1 Whenever a complaint is received against the Standard Marked product of the licensee, the licensee shall carry out investigation as per IS/ISO 10002 and take appropriate actions to redress the complaint under intimation to BIS, which may include repair or free replacement of the product. If the complainant is not satisfied with the redress and lodges complaint with BIS, then BIS will carry out an investigation and the findings of such investigation and the redress so decided by BIS shall be binding on the licensee.

2 In the event of any damage caused by the products bearing the Standard Mark, or claim being filed by the consumer against BIS Standard Mark, entire liability arising out of such non- conforming product shall be of the licensee and BIS shall not, in any manner, be responsible in such cases.

RENEWAL OF LICENCE

1 The initial validity period of the licence is one year. The licence may be renewed for further period of one year or two years subject to its satisfactory operation, as observed during the surveillance inspections, conformity of factory and market samples to the relevant Indian Standard in independent testing, satisfactory redress of consumer’s complaints, if any, etc.

2 The licensee shall apply to BIS on the Renewal Application Form along with the renewal application fee, the annual licence fee (for one or two years as applicable) and the Annual Minimum Marking Fee or the marking fees calculated on unit rate basis, whichever is higher (less the amount already paid as the quarterly fee) at least one month before the validity of the licence. The production statement, on the basis of which the marking fee is calculated, shall also be required to be got certified from a Chartered Accountant.

THANK YOU